Randomized trial of HPV4 vaccine assessing the response to HPV4 vaccine in two schedules among Peruvian female sex workers

Two hundred female sex workers (FSWs) in Lima, Peru were randomized to receive HPV4 vaccine in the standard (0, 2, 6 months) or a modified schedule (0, 3, 6 months). One hundred and eighty four (92%) participants completed 3 doses of vaccine. Baseline seropositive rates were 58% for HPV6, 22.5% for HPV11, 41.5% for HPV16, and 13% for HPV18. The final geometric mean antibody titer (GMT) following vaccination was significantly greater for women who were seropositive at baseline compared to seronegative women: HPV6 (GMT ratio = 2.3, p < 0.01), HPV11 (GMT ratio = 2.7, p < 0.01), HPV16 (GMT ratio = 1.3, p = 0.04), and HPV18 (GMT ratio = 2.4, p < 0.01). Antibody titers in the modified schedule were not inferior to those in the standard schedule, suggesting the modified schedule may be paired with required STD visits. Although all women benefit from vaccination, administration at a younger age and before sexual debut is needed to achieve maximum protection from vaccine.

► Female sex workers in Peru were randomized to receive HPV4 in two study schedules.
► More women were seropositive for any HPV4 genotype at baseline than DNA positive.
► We achieved high vaccine completion, and nearly all women had an immune response.
► Antibody titers in the modified schedule were not inferior to the standard schedule.
► Vaccination before sexual debut is needed to achieve maximum protection.